3M Bair Hugger™ Warming Units Operating instructions

Model 775

Warming Unit

Operator’s Manual

Normothermia System

- Unidade de Aquecimento

3M™ Bair Hugger™, Modelo 775

Manual do Usuário

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I 3M™ Bair Hugger™ 775 型加温器

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1 3M™ Bair Hugger™

Warming Unit Model 775

Operator’s Manual

2 areil de réchauffement

Bair Hugger™ 3M™, modèle 775

Manuel de l’utilisateur

3 3M™ Bair Hugger™-Wärmeeinheit,

Modell 775

Bedienungsanleitung

4 Unità riscaldante

3M™ Bair Hugger™ modello 775

Manuale d’uso

5 Unidad de calentamiento

modelo 775 Bair Hugger™ de 3M™

Manual del operador

6 3M™ Bair Hugger™-verwarmingsunit

model 775

Bedieningshandleiding

7 3M™ Bair Hugger™ värmeenhet,

modell 77521

Användarhandbok

8 3M™ Bair Hugger™ varmeenhed,

model 775

Betjeningsvejledning

9 3M™ Bair Hugger™ Varmeenhet,

modell 775

Brukerhåndbok

0 3M™ Bair Hugger™

-lämpöpuhallinmalli 775

Käyttöopas

3M™ Bair Hugger™   775 

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Model 775

Warming Unit

Operator’s Manual

Normothermia System

Description:

Base File Name:

Software:

SGS Contact:

Email:

Printer:

Printer Location:

Supplier:

3M

TM

Bair Hugger™

Patient Adjustable Warming Unit

Requester:

Frank Boeshart/Debra Staack

Reference:

Die # / Doc. Size:

8.5" x 11"

Item Spec#:

34-8718-8811-0

Supersedes#:

Cat/Product#:

Model 775

Structure#:

Manual

PA: 34871888110.indb

GA:

InDesign CC 2014 - BOOK

PROCESS

BLACK

PMS

280

4394547

5

08.02.16 New Build kmh

08.04.16 Updated Final pages number. Jer

08.25.16 Alts per PDF ﬁle kmh

08.30.16 Final release. DJ

09.24.16 Adjust Center Margins to 1 in. to accomodate spiral binding and Final Release kmh

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1

GB / 34-8718-8811-0

1 Table of Contents

Introduction................................................................................................................................................................................... 3

Description Of The 3M™ Bair Hugger™ Temperature Management System ......................................................... 3

Indications.............................................................................................................................................................................. 3

Denition Of Symbols ......................................................................................................................................................... 3

Contraindications, Warnings, Cautions And Notices ........................................................................................................... 3

Explanation Of Signal Word Consequences................................................................................................................... 3

CONTRAINDICATION: ...................................................................................................................................................... 4

WARNING: ............................................................................................................................................................................ 4

CAUTION: ............................................................................................................................................................................. 4

Notices ................................................................................................................................................................................... 5

Proper Use And Maintenance............................................................................................................................................ 5

Read Before Servicing Equipment .................................................................................................................................... 5

Overview And Operation............................................................................................................................................................ 5

Warming Unit Power-On-Reset......................................................................................................................................... 6

Overview Of Control Panel................................................................................................................................................ 6

Mounting The Warming Unit To An IV Pole .....................................................................................................................7

Instructions For Use......................................................................................................................................................................7

Viewing The Temperature Mode Timer............................................................................................................................7

What To Do In Case Of An Over-Temperature Condition ............................................................................................7

What To Do If A Fault Condition Occurs..........................................................................................................................7

General Maintenance And Storage .......................................................................................................................................... 8

Cleaning Instructions........................................................................................................................................................... 8

Storage ................................................................................................................................................................................... 8

Technical Service And Order Placement ................................................................................................................................8

When You Call For Technical Support ............................................................................................................................. 8

In-Warranty Repair And Exchange ................................................................................................................................... 8

Specications........................................................................................................................................................................ 8

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GB / 34-8718-8811-0

1 3M™ BairHugger™ Warming Unit Model775

Operator’sManual

Introduction

Description of the 3M™ BairHugger™ Temperature

ManagementSystem

The BairHugger temperature management system consists of a

Model 775warming unit (with optional rolling stand, and other

accessories) along with a 3Mwarming blanket, BairHugger warming

gown, or the 3M™ Ranger™ 241blood/fluid warmingset.

The BairHugger warming unit is attached to the warming blanket or

warming gown by means of a flexible hose. Warm air is generated

in the warming unit and flows through the warming unit hose and

into the blanket or gown. Depending on the model, the 3Mblanket

or gown is placed either around, over, or underneath the patient.

Small perforations on the blanket or gown allow the warm air to be

dispersed over the patient. For blood/fluid warming applications, the

Model 241blood/fluid warming set is inserted in the warming unit

hose. When the warming unit is turned ON and a temperature setting

is selected, warm air flows over the Model 241tubing and warmed

blood/fluid exits from the distal end of the tubing. For additional

information on 3Mblankets, gowns, the 241warming set, or other

accessories visit us online atbairhugger.com.

This manual includes operating instructions and warming unit

specifications for the Model 775warming unit. You can use the

Model 775warming unit in all clinical settings where the patient may

feel too warm or too cold; including the operating room to provide

patient temperature management. For information about using

3Mblankets, gowns or the 241blood/fluid warming set with the

Model 775warming unit, refer to the respective Instructions forUse.

Indications

The BairHugger temperature management system is intended

to prevent and treat hypothermia. In addition, the temperature

management system can be used to provide patient thermal comfort

when conditions exist that may cause patients to feel too warm or too

cold. The temperature management system can be used with adult

and pediatricpatients.

• The BairHugger temperature management system should

only be used by trained medicalprofessionals.

• Federal law (USA) restricts this device to sale by or on the

order of a licensed healthcareprofessional.

Definition ofSymbols

The following symbols may appear on the product’s labeling or

exteriorpackaging.

An equipotentiality plug (grounded) conductor

other than a protective earth conductor or a

neutral conductor, providing a direct connection

between electrical equipment and the potential

equalization busbar of the electrical installation.

Please consult IEC 60601-1 forrequirements.

Fuse

Type BF equipment (patientapplied)

Date ofmanufacture

Manufacturer

Voltage, alternating current(AC)

This system is subject to European WEEE

Directive2002/96/EC. This product contains

electrical and electronic components and

must not be disposed of using standard refuse

collection. Please consult local directives for

disposal of electrical and electronicequipment.

Protective earthground

No freehosing

High fansetting

Low fansetting

Non-explosionproof

Consult instructions foruse

Follow instructions foruse

Recycle to avoid environmental contamination.

This product contains recyclable parts. For

information on recycling, please contact your

nearest 3MService Center foradvice.

Attention; see instructions foruse

Keepdry

Temperaturelimit

Contraindications, Warnings, Cautions andNotices

Explanation of Signal WordConsequences

!

WARNING: Indicates a hazardous situation which, if not

avoided, could result in death or seriousinjury.

!

CAUTION: Indicates a hazardous situation which, if not

avoided, could result in minor or moderateinjury.

NOTICE: Indicates a situation which, if not avoided, could result in

property damageonly.

4

3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual

!

CONTRAINDICATION: To reduce the risk of thermalinjury:

• Do not apply heat to lower extremities during aortic

cross-clamping. Thermal injury may occur if heat is applied

to ischemiclimbs.

!

WARNING: To reduce the risk of thermalinjury:

• The BairHugger Model 775warming unit has been

designed to operate safely ONLY with 3Mdisposable

warming products. Use with other products may cause

thermal injury. To the full extent permitted by law, the

manufacturer and/or importer declines all responsibility for

thermal injury resulting from the warming unit being used in

conjunction with non-3Mproducts.

• Do not treat patients with the warming unit hose

alone. Always attach the hose to a 3Mwarming

blanket/gown before providing warmingtherapy.

• Do not allow the patient to lie on the warming unithose.

• Do not allow the warming hose to directly contact the

patient’s skin during warmingtherapy.

• Do not leave neonates, infants, children and other

vulnerable patient populations unattended during

warmingtherapy.

• Do not leave patients with poor perfusion unmonitored

during prolonged warmingtherapy.

• Do not place the non-perforated side of the warming

blanket/gown on the patient. Always place the perforated

side (with the small holes) directly on top of the patient in

contact with the patient’sskin.

• Do not connect a torn or damaged warming blanket/gown

to the warmingunit.

• For over-body warming blankets and gowns; do not place

patient securement device (i.e. safety strap or tape) over

the warmingblanket/gown.

• For underbody or side channel warming blankets; if a

securement device (i.e. safety strap, tape) is used, ensure

the warming channels are notoccluded.

• Do not place the warming blanket/gown directly over a

dispersive electrodepad.

• Do not continue warming therapy if the red Over-temp

indicator light illuminates and the alarm sounds. Unplug the

warming unit and contact a qualified servicetechnician.

• Do not continue 241blood/fluid warming therapy if the

red Over-temp indicator light illuminates and the alarm

sounds. Immediately stop fluid flow, and discard the blood/

fluid warming set. Unplug the warming unit, and contact a

qualified servicetechnician.

• For the BairHugger flex warming gown; ensure that the

blood pressure cuff, ECG, IV or other lines or cords are

not between the upper sleeve insert and the gown prior to

deploying the upper sleeve warming insert(s), as this could

result in tearing of the insert duringdeployment.

• Do not perform the over-temperature detection system test

while the warming unit is being used for warmingtherapy.

!

WARNING: To reduce the risk of patient injury or death due to

altered drugdelivery:

• Do not use a warming blanket/gown over transdermal

medicationpatches.

!

WARNING: To reduce the risk of injury due to interference

withventilation:

Do not allow the warming blanket/gown or head drape to

cover the patient’s head or airway when the patient is not

mechanicallyventilated.

!

WARNING: To reduce the risk of injury due to patientfalls:

• Do not use a warming blanket/gown to transfer or move

thepatient.

!

WARNING: To reduce the risks associated with hazardous

voltage andfire:

• Keep power cord visible and accessible at all times. The

plug on the power cord serves as the disconnectdevice.

• Only connect to outlets marked “Hospital only,” “Hospital

Grade,” or a reliable groundedoutlet.

• Use only the power cord specified for this product and

certified for the country ofuse.

• Do not allow the power cord to getwet.

• Do not use the warming unit when it appears the warming

unit, power cord or any component is damaged. Replace

the warming unit. Contact 3MTechnicalSupport.

• Do not disassemble the warming unit unless you are a

qualified service technician. There are electrically live

parts within the warming unit when it is connected to a

powersource.

• Connect each warming unit being tested to a separate

powersource.

!

CAUTION: To reduce the risk ofcross-contamination:

• Except for specific BairHugger warming blanket models,

3Mwarming blankets/gowns are not sterile. Each warming

blanket/gown is intended for single patient use ONLY.

Placing a sheet between the warming blanket/gown and

the patient does not prevent contamination of theproduct.

• Clean the warming unit and the outside of the warming unit

hose after each patient use. See “Cleaning Instructions” on

page8.

• Follow applicable regulations when disposing of this

warming unit or any of its electricalcomponents.

• Do not attempt to clean the air filter as it may be

contaminated from use. Discard the filter in a manner

consistent with institutionalprotocol.

• Do not operate the BairHugger warming unit with the

hose detached from the 3Mwarming blanket/gown. The

BairHugger warming unit is intended to be used with

the hose properly attached to its corresponding warming

blanket/gown and in accordance with good practices for

operating room steriletechnique.

!

CAUTION: To reduce the risk of patient or caregiverinjury:

• If mounted on an IV pole, the distance from the bottom of

the warming unit to the floor must be less than 44” (112cm)

and the IV pole wheelbase diameter must be at least 28”

(71cm) to preventtipping.

!

CAUTION: To reduce the risk offire:

• 3Mwarming blankets and gowns are classified as Class I

Normal Flammability as defined by the Consumer Product

Safety Commissions flammable fabric regulation, 16CFR

1610. Follow standard safety protocols when using high

intensity heatsources.

!

CAUTION: To reduce the risk of thermal injury, hyperthermia

orhypothermia:

• 3Mrecommends continuously monitoring core

temperature. In the absence of continuous monitoring,

monitor the temperature of patients who are incapable

of reacting, communicating and/or who cannot sense

temperature a minimum of every 15minutes or according to

institutionalprotocol.

5

GB / 34-8718-8811-0

• Monitor cutaneous responses of patients who are incapable

of reacting, communicating and/or who cannot sense

temperature a minimum of every 15minutes or according to

institutionalprotocol.

• Adjust air temperature or discontinue therapy when the

therapeutic goal is reached, if elevated temperatures are

recorded or if there is an adverse cutaneous response in the

warmedarea.

• Do not place the warming unit on a soft uneven surface,

such as a bed, or a visibly wet surface as the air intake may

become blocked and cause the warming unit to overheat,

compromising the warming unit’sperformance.

• Perform all temperature testing of the warming unit with a

3MModel 22110temperature testunit.

!

CAUTION: To reduce the risk associated with

electromagnetic interference (EMI) due to portable and

mobile radio frequency (RF) communicationsequipment:

• The 3MBairHugger temperature management system has

been tested to be resistant to both EMI and electrostatic

discharge(ESD).

• Install and put into service the 3MBairHugger temperature

management system according to the electromagnetic

compatibility (EMC) information provided in the Guidance

and Manufacturer’sDeclaration.

• Should interference occur, move away from the portable or

mobile RF communicationsequipment.

Notices

1. The BairHugger warming unit meets medical electronic

interference requirements. If radio frequency interference with

other equipment should occur, connect the warming unit to a

different powersource.

2. To avoid warming unitdamage:

• Use proper Electrostatic Discharge (ESD) procedures when

performingmaintenance.

• Do not modify this equipment without authorization from

themanufacturer.

• Do not immerse the warming unit, warming unit parts

or accessories in any liquid or subject them to any

sterilizationprocess.

• Do not use cleaning solutions with greater than 80%

alcohol or solvents, including acetone and thinner, to clean

the warming unit or hose. Solvents may damage the labels

and other plastic parts.

Proper Use andMaintenance

3Massumes no responsibility for the reliability, performance, or

safety of the warming unit if the following eventsoccur:

• Modifications or repairs are performed by

unqualifiedpersonnel.

• The warming unit is used in a manner other than that

described in the Operator’s or ServiceManual.

• The warming unit is installed in an environment

that does not meet the appropriate electrical and

groundingrequirements.

• The warming unit not maintained in accordance with the

procedures described in the ServiceManual.

Read Before ServicingEquipment

All repair, calibration and servicing of the warming unit require the

skill of a qualified, medical equipment service technician who is

familiar with good practice for medical device repair. If service does

not require the manufacturer’s attention, the Model 775Service

Manual provides the technical information needed to service the

warming unit. Perform all repairs and maintenance in accordance

with the instructions in the Service Manual. For additional service

information please contact 3Mtechnicalsupport.

Overview andOperation

Figure B. Model 775Warming Unit – rearview

IV pole clamp

Hose

Hose connection

Power cord

connection

Figure A. Model 775Warming Unit – frontview

Alphanumeric

display

Control Panel

Carrying

handle

Warming UnitPower-On-Reset

The Model 775warming unit automatically performs the following

power-on-reset sequence after you connect the warming unit to a

properly grounded powersource:

• Performs all self-testfunctions.

• Illuminates indicator lights and all pixels in the

alphanumeric displaymomentarily.

• Displays the text “MD 700’s” and the software revision

level in the alphanumericdisplay.

• Sounds the alarm (three low-levelclicks).

• Enters the Standby mode with the high fan setting selected

bydefault.

Note: The low fan setting indicator light will not illuminate

during powerup.

If the warming unit loses power for less than 1second, the warming

unit software will return the warming unit to the operating mode

you selected prior to the power loss. However, if the warming unit

loses power for longer than 1second, the warming unit software will

reset when you restore power. The warming unit will then enter the

Standby mode with the high fan setting selected bydefault.

6

3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual

Overview of ControlPanel

TEMP IN RANGE

FAULT

OVER TEMP

STANDBY

AMBIENT

MODEL

775

43 C

MEDIUM

HIGH

TEMPERATURE

AIR FLOW

38 C

LOW

32 C

System

High Fan

Setting

Alphanumeric Display

Temperature

Modes

Low Fan

Setting

Figure C. Model 775 Warming Unit Control Panel

ALPHANUMERICDISPLAY

The alphanumeric display shows the temperature at the end of the

BairHugger warming unit hose in degreesCelsius.

TEMPERATUREMODES

• Press the 32˚C (Low), 38˚C (Med), or 43˚C (High) button to

select the desiredtemperature.

• Press the Ambient button to supply room temperatureair.

When you select a temperature mode, the following eventsoccur:

• Corresponding temperature indicator and fan setting

lightsilluminate.

• Blower operates at selected fanspeed.

• Temperature at the end of the hose appears in the

alphanumericdisplay.

• Heater activates except in ambientmode.

• Temperature mode timer and hour meteractivate.

• Temp in range indicator light illuminates when the

temperature at the blanket end of the hose is within +/-

1.5°C of the selected setting; this indicator light does not

illuminate in the ambientmode.

AIRFLOWMODES

The Model 775warming unit has two preset fan speed settings: a

default or high fan setting (

) and a reduced or low fan setting ( ).

The Model 775warming unit will reset/default to the high fan setting

each time the warming unit is powered up or Standby is selected.

The low fan setting ( ) may be pre-selected while in Standby prior to

selecting the desiredtemperature.

STANDBY

Upon power up, the warming unit defaults to Standby and the high

fan setting. When the warming unit is in 32˚C (Low), 38˚C (Med), or

43˚C (High) or Ambient mode, press the Standby button to place the

warming unit in Standby mode. When you select the Standby mode,

the following eventsoccur:

• Standby indicator lightilluminates.

• Blower and heater are turnedOFF.

• Alphanumeric displaydeactivates.

• Alarm and fault detection functions remainactive.

• Operating timerpauses.

• Airflow mode resets/defaults to the high fansetting.

TEMP IN RANGE INDICATORLIGHT

The Temp in Range indicator light illuminates when the temperature at

the blanket or gown end of the hose is ±1.5°C of the selected setting;

this indicator light does not illuminate in the ambientmode.

FAULT INDICATORLIGHT

When a system fault occurs, the amber Fault indicator light flashes

and an audible alarm sounds. Please refer to What to Do in Case of a

Fault Condition on page 7for additionalinformation.

UNDER-TEMPFAULT

If the warming unit senses an under-temperature condition, the

amber Fault indicator light flashes and an audible alarm sounds.

Please refer to What to Do in Case of a Fault Condition on page 7for

additionalinformation.

OVER-TEMP INDICATORLIGHT

If the warming unit senses an over-temperature condition, the red

Over-temp indicator light flashes and an alarm sounds. Please refer to

What to Do in Case of an Over-Temperature Condition on page 7 for

additionalinformation.

Mounting the Warming Unit to an IVPole

To prevent tipping, clamp the Model 775warming unit to an IV pole

at a height that provides stability. Clamp the warming unit no higher

than 44” (112cm) from the floor on an IV pole with a minimum 28”

(71cm) diameterwheelbase.

!

Caution: If mounted on an IV pole, the distance from the

bottom of the warming unit to the floor must be less than 44”

(112cm) and the IV pole wheelbase diameter must be at least

28” (71cm) to preventtipping.

METHOD

To mount the Model 775warming unit to an IV pole, simply

turn the clamp handle clockwise to tighten the clamp on

the IV pole and counterclockwise to release it. Ensure

the IV pole bumper rests against the pole. See FigureD.

28 in.

(71 cm) minimum

44 in. (112 cm)

maximum

Figure D. Model 775 warming unit on an IV Pole

IV Pole

Bumper

Clamp

Handle

7

GB / 34-8718-8811-0

INSTRUCTIONS FORUSE

The instructions below describe how to operate the Model

775warming unit. For information about using 3Mblankets, gowns,

or the 241blood/fluid warming set with the Model 775warming unit,

refer to the respective Instructions forUse.

1. If the Model 775warming unit is not mounted on an IV pole or

BairHugger rolling stand, place the warming unit on a flat, hard,

dry surface, such as a table, before beginning warmingtherapy.

!

Caution: Do not place the warming unit on a soft uneven

surface, such as a bed, or a visibly wet surface as the air

intake may become blocked and cause the warming unit to

overheat, compromising the warming unit’sperformance.

2. Insert the end of the BairHugger warming unit hose in the

warming blanket or gown hose port. Use a twisting motion to

ensure a snug fit. A visual marker is located around the

mid-section of the hose end to guide the depth of hose

insertion. (Figures E). Support the hose to ensure

secureattachment.

!

Warning: Do not treat patients with the BairHugger

warming unit hose alone. Always attach the hose to a

BairHugger warming blanket/gown before providing

warmingtherapy.

Insert

marker

Figure E.

Hose port

Hose

3. Connect the warming unit to a properly grounded power

source. The warming unit will be in Standby mode and

the Standby indicator light will illuminate. The high fan

setting ( ) will be pre-selected by default with its indicator

light illuminated. The low fan setting (

) may be pre-selected

prior to selecting the desired temperaturemode.

4. Press the appropriate button (i.e., 32˚C, 38˚C, 43˚C, or

Ambient) to select the desired temperature. This will turn

the blower and heater ON. When the warming unit reaches

the selected temperature, the Temp in Range indicator light

will illuminate; this indicator light does not illuminate in the

Ambientmode.

!

Caution: Patient MonitoringRecommendations:

• 3Mrecommends continuously monitoring core

temperature. In the absence of continuous monitoring,

monitor the temperature of patients who are incapable

of reacting, communicating and/or who cannot sense

temperature a minimum of every 15minutes or according to

institutionalprotocol.

• Monitor cutaneous responses of patients who are incapable

of reacting, communicating and/or who cannot sense

temperature a minimum of every 15minutes or according to

institutionalprotocol.

• Adjust air temperature or discontinue therapy when the

therapeutic goal is reached, if elevated temperatures are

recorded or if there is an adverse cutaneous response in the

warmedarea.

5. Press the Standby button when warming therapy is complete.

Disconnect the warming unit hose from the warming blanket/

gown and discard the blanket/gown per hospitalpolicy.

6. Unplug the warming unit to disconnect it from the

powersource.

Note: At any time, the fan speed setting can be switched between

high fan setting ( ) and low fan setting ( ) by pressing the

corresponding button. However, these buttons will not place the

warming unit into Standby.

Viewing the Temperature ModeTimer

The temperature mode timer records the amount of time the warming

unit has been operating in the selected temperature mode. The timer

resets itself every time you select a different temperature mode.

To view the temperature mode timer, press the button and hold for

3seconds for the current temperature mode. The alphanumeric

display will show the temperature mode time, then go back to

showing the temperature modesetting.

What to Do in Case of an Over-TemperatureCondition

If an over-temperature condition occurs, the red Over-temp indicator

light flashes and an audible alarm sounds and the warming unit

automatically turns OFF the heater, blower, and operating mode

indicator lights. A fault code appears in the alphanumericdisplay.

Note: Pressing any button will silence thealarm.

IF AN OVER-TEMPERATURE CONDITIONOCCURS:

!

Warning: Do not continue warming therapy if the red

Over-temp indicator light illuminates and the alarm

sounds. Unplug the warming unit and contact a qualified

servicetechnician.

!

Warning: Do not continue 241blood/fluid warming therapy

if the red Over-temp indicator light illuminates and the alarm

sounds. Immediately stop fluid flow, and discard the blood/fluid

warming set. Unplug the warming unit, and contact a qualified

servicetechnician.

1. Discontinue all warming therapy. If you are using the 241blood/

fluid warming set, immediately stop fluid flow and discard the

blood/fluid warmingset.

2. Press any button on the control panel to silence thealarm.

3. Unplug the warmingunit.

4. Replace warming unit. Do not attempt to restart or reset the

warmingunit.

5. Contact a qualified servicetechnician.

What to Do If a Fault Conditionoccurs

The Model 775warming unit software recognizes several

non-hazardous conditions and reports those conditions as faults.

When a system fault occurs, the software stores the fault code

in memory, the amber Fault indicator light flashes, and an alarm

sounds. The warming unit automatically turns the heater, blower,

and operating mode indicator lights OFF. The control panel will not

respond tocommands.

Note: Pressing any button will silence thealarm.

IF A FAULT CONDITIONOCCURS:

1. Unplug the warming unit and wait for 30-60seconds.

2. Reconnect the warming unit to a grounded power source. The

warming unit will perform the normal power-on-reset sequence

and then enter the Standbymode.

3. Reselect the temperaturesetting.

4. If the warming unit does not return to normal operation, contact

a qualified servicetechnician.

8

3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual

General Maintenance andStorage

CleaningInstructions

1. Disconnect the warming unit from the power source

beforecleaning.

2. Cleaning should be performed in accordance with hospital

practices for cleaning OR equipment. After every use; wipe

the warming unit, the outside of the warming unit hose, and

any other surfaces that may have been touched. Use a damp,

soft cloth and a hospital approved mild detergent, germicidal

disposable wipes, disinfecting towelettes, or antimicrobial

spray.

3. Let air dry or dry with a separate clean softcloth.

Notice:

• Do not use cleaning solutions with greater than 80%

alcohol or solvents, including acetone and thinner, to clean

the warming unit or hose. Solvents may damage the labels

and other plasticparts.

• Do not immerse the BairHugger warming unit, warming

unit parts, or accessories in any liquid or subject them to

any sterilization process.

STORAGE

Store all components in a cool, dry place when not inuse.

Technical Service and OrderPlacement

USA

+1-800-733-7775

OUTSIDEUSA

Contact your local service provider ordistributor.

When You Call for TechnicalSupport

We will need to know the serial number of your BairHugger

warming unit. The serial number label is located on the back of the

warmingunit.

In-Warranty Repair andExchange

USA

Call 3Mcustomer service if your Model 775warming unit requires

factory service. A customer service representative will give you a

Return Authorization (RA) number. Please use this RA number on

all correspondence concerning your warming unit. Your customer

service representative will also send a shipping carton to you at no

charge, if needed. Call your local supplier or sales representative

to inquire about borrowing a warming unit while we service your

warming unit. For more detailed instructions on returning warming

units for service, please refer to the Model 775ServiceManual.

OUTSIDE OF THEUSA

Contact your local distributor concerning in-warranty repair

andexchange.

Specifications

PhysicalCharacteristics

DIMENSIONS

13" high x 13" deep x 14" wide (33cm high x 33cm deep x

36cmwide)

WEIGHT

16lb(7.3kg)

RELATIVE NOISELEVEL

53dBA (High fansetting)

48dBA (Low fansetting)

HOSE

Flexible, compatible with the Ranger 241blood/fluid warmingset.

Length: 80" (203cm)

UNIT INTAKEFILTER

MERV14*

* See Frequently Asked Questions on Filtration (p.243)

RECOMMENDED FILTERCHANGE

Every 12months or 500hours ofuse.

MOUNTING

Can be clamped to an IV pole, placed on a hard surface, or mounted

to the rolling standaccessory.

TemperatureCharacteristics

RECOMMENDED OPERATING

ENVIRONMENTTEMPERATURE

15°C-25°C

HUMIDITY

Max relative humidity 80% (up to 31°C) decreasing linearly to 50%

relative humidity at40°C.

ALTITUDE

Max2,000m

TEMPERATURECONTROL

Electronicallycontrolled

HEATGENERATED

High fan setting: 1600BTU/hr (average), 470W(average)

Low fan setting: 1330BTU/hr (average), 390W(average)

OPERATINGTEMPERATURES

Average temperatures at the end of thehose:

HIGH:43° ± 1.5°C (109.4° ±2.7°F)

MED:38° ± 1.5°C (100.4° ±2.7°F)

LOW:32° ± 1.5°C (89.6° ±2.7°F)

TIME TO REACH OPERATINGTEMPERATURE

2 - 5minutes (dependent on blanketmodel)

Time required for the contact surface temperature to heat up from

23± 2°C to 37°C (73± 2°F to99°F).

STORAGE/TRANSPORTTEMPERATURE

-20°C to 45°C (-4°F to113°F)

Store all components in a cool, dry place when not inuse.

9

GB / 34-8718-8811-0

SafetySystem

THERMOSTAT

Independent electronic circuit; thermal cutoff shuts the heater OFF

to ensure hose end air remains below 56°C (53°C ± 3°C typical);

back-up over-temperature detection at warming unit hoseinlet.

ALARMSYSTEM

Over-temperature (≤56°C, 53°C ± 3°C typical): red Over-Temp

indicator light flashes, alarm sounds, heater and blower shut

down, operating indicator lights turn OFF, and control panel

becomesunresponsive.

FAULT

Amber Fault indicator light flashes, alarmsounds.

OVERCURRENTPROTECTION

Dual input fusedlines.

ElectricalCharacteristics

HEATINGELEMENT

1400WResistive

LEAKAGECURRENT

Meets UL 60601-1and IEC 60601-1requirements.

BLOWERMOTOR

Operating speed: 4,700rpm (high fansetting)

4,100rpm (low fansetting)

Airflow: up to 48cfm or 23L/s

POWERCONSUMPTION

Peak: 1550W

Average: 800W

POWERCORD

15ft., SJT, 3cond., 13A

15ft., SJT, 3cond., 15A

4.6m, HAR, 3cond., 10A

DEVICERATINGS

110-120VAC, 50/60Hz, 11.7A,or

220-240VAC, 50/60Hz, 7.2A,or

100VAC, 50/60Hz, 15A

FUSES

TYPE

Fast acting ceramic fuses, 250VAC

AMPRATING

12A (110 - 120VAC)

8A (220 - 240VAC)

15A (100VAC)

OPERATINGSPEED

F (FastActing)

BREAKINGCAPACITY

15A, 12A: 750A @ 250Vac

15A, 12A: 10,000A @ 125Vac

8A: 200A @ 250Vac

8A: 10,000A @ 125Vac

CERTIFICATIONS

IEC 60601-1; IEC/EN 60601-1-2; UL 60601-1; CAN/CSA-C22.2,

No.601.1; EN 55011; EN80601-2-35

10

3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual

CLASSIFICATION

Guidance and manufacturer’s declaration – electromagneticemissions

The Model 775warming unit is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the Model

775warming unit should assure that it is used in such anenvironment.

Emissions test Compliance Electromagnetic environment -guidance

RFemissions

CISPR 11

Group 1 The Model 775warming unit uses RF energy only for its internal function. Therefore,

its RF emissions are very low and are not likely to cause any interference in nearby

electronicequipment.

RFemissions

CISPR 11

Class B The Model 775warming unit is suitable for use in all establishments, including domestic

establishments and those directly connected to the public low-voltage power supply

network that supplies buildings used for domesticpurposes.

Harmonicemissions

IEC 61000-3-2

Class A

Voltagefluctuations/

Flickeremissions

IEC 61000-3-3

Complies

Guidance and manufacturer’s declaration – electromagneticimmunity

The Model 775warming unit is intended for use in the electromagnetic environment specifiedbelow. The customer or the user of the Model

775warming unit should assure that it is used in such anenvironment.

Immunity Test IEC60601 test level Compliance level Electromagnetic environment -guidance

Electrostatic

discharge(ESD)

IEC 61000-4-2

±6kVcontact

±8kV air

±6kVcontact

±8kV air

Floors should be wood, concrete or ceramic tile. If floors are

covered with synthetic material, the relative humidity should

be at least30%.

Electrical

fasttransient/burst

IEC 61000-4-4

±2kV for power

supplylines

±1kV for input/output

lines

±2kV for power

supplylines

±1kV for input/output

lines

Mains power quality should be that of a typical commercial or

hospitalenvironment.

Surge

IEC 61000-4-5

±1kV line toline

±2kV line(s) to earth

±1kV line toline

±2kV line(s) to earth

Mains power quality should be that of a typical commercial or

hospitalenvironment.

Voltage dips, short

interruptions and

voltage variations

on power supply

inputlines

IEC 61000-4-11

<5% U

T

(>95% dip in U

T

)

for 0,5cycle

40% U

T

(60% dip in U

T

)

for 5cycles

70% U

T

(30% dip in U

T

)

for 25cycles

<5% U

T

(>95% dip in U

T

)

for 5sec

<5% U

T

(>95% dip in U

T

)

for 0,5cycle

40% U

T

(60% dip in U

T

)

for 5cycles

70% U

T

(30% dip in U

T

)

for 25cycles

<5% U

T

(>95% dip in U

T

)

for 5sec

Mains power quality should be that of a typical commercial or

hospital environment. If the user of the Model 775warming

unit requires continued operation during power mains

interruptions, it is recommended that the Model 775warming

unit be powered from an uninterruptible power supply or

abattery.

Power frequency

(50/60Hz)

magneticfield

IEC 61000-4-8

3A/m 3A/m Power frequency magnetic fields should be at levels

characteristic of a typical location in a typical commercial or

hospitalenvironment.

NOTE U

T

is the a.c. mains voltage prior to application of the testlevel.

11

GB / 34-8718-8811-0

Guidance and manufacturer’s declaration – electromagneticimmunity

The Model 775warming unit is intended for use in the electromagnetic environment specified below. The customer or the user of the Model

775warming should assure that it is used in such anenvironment.

Immunity Test IEC 60601test level Compliance

level

Electromagnetic environment -guidance

ConductedRF

IEC61000-4-6

RadiatedRF

IEC 61000-4-3

3Vrms

150kHz to 80MHz

3V/m

80MHz to 2,5GHz

3Vrms

3V/m

Portable and mobile RF communications equipment should be used no

closer to any part of the Model 775warming unit, including cables, than

the recommended separation distance calculated from the equation

applicable to the frequency of thetransmitter.

Recommended separationdistance

d =1.2

d = 1.2 80MHz to 800MHz

d = 2.3

800MHz to 2,5GHz

where P is the maximum output power rating of the transmitter in watts

(W) according to the transmitter manufacturer and d is the recommended

separation distance in meters(m).

Field strengths from fixed RF transmitters, as determined by an

electromagnetic site survey

a

, should be less than the compliance level in

each frequencyrange.

b

Interference may occur in the vicinity of equipment marked with the

followingsymbol:

NOTE 1 At 80MHz and 800MHz, the higher frequency rangeapplies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from

structures, objects andpeople.

a

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio,

AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment

due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which

the Model 775warming unit is used exceeds the applicable RF compliance level above, the Model 775warming unit should be observed to

verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the

Model 775warmingunit.

b

Over the frequency range 150kHz to 80MHz, field strengths should be less than 3V/m.

Recommended separation distancesbetween portable and mobile RF communications equipment and the Model 775warmingunit

The Model 775warming unit is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The

customer or the user of the Model 775warming unit can help prevent electromagnetic interference by maintaining a minimum distance

between portable and mobile RF communications equipment (transmitters) and the Model 775warming unit as recommended below,

according to the maximum output power of the communicationsequipment.

Rated maximum output power of

transmitter W

Separation distance according to frequency of transmitterm

150kHz to 80MHz

d =1.2

80MHz to800MHz

d =1.2

800MHz to 2,5GHz

d =2.3

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated

using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts

(W) according to the transmittermanufacturer.

NOTE 1 At 80MHz and 800MHz, the separation distance for the higher frequency rangeapplies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from

structures, objects andpeople.

12

3M™Bair Hugger™ Model 775 Warming Unit – Operator’s Manual

MEDICAL — GENERAL MEDICAL EQUIPMENT AS TO

ELECTRICAL SHOCK, FIRE AND MECHANICAL

HAZARDS ONLY IN ACCORDANCE WITH UL 60601-1;

CAN/CSA-C22.2, No.601.1; ANSI/AAMI

ES60601-1:2005CSA-C22.2No. 60601-1:08;

EN80601-2-35; ControlNo.4HZ8

Classified under IEC 60601-1Guidelines (and other national

versions of the Guidelines) as Class I, Type BF, Ordinary equipment,

Continuous operation. Not suitable for use in the presence of

flammable anesthetic mixtures with air or with oxygen or nitrous

oxide. Classified by Underwriters Laboratories Inc. with respect to

electric shock, fire and mechanical hazards only, in accordance with

UL 60601-1, EN 80601-2-35and in accordance with Canadian/CSA

C22.2, No. 601.1. Classified under the Medical Device Directive as a

Class IIbdevice.

DIAGNOSTICS

A qualified service technician can perform over-temperature

detection system testing, temperature output testing, operating

temperature calibration, and fault codetroubleshooting.

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243

FAQ / 0-8811-8718-34

Frequently Asked Questions (FAQ) on Filtration

What filter is used in the 3M™ Bair Hugger™ Model 775 warming unit?

The Model 775 uses the same lter media as has for many years been used with prior Bair Hugger -700series models. That lter media is

classied on an industry-standard scale as MERV 14 at 48 CFM (cubic feet per minute) under ASHRAE Standard 2012-52.2: Method of

Testing General Air Ventilation Air-Cleaning Devices for Removal Eciency by Particle Size.1,2

What is a MERV rating?

The Minimum Eciency Reporting Value, or MERV, is a measurement scale to rate the eciency of an air lter as a

function of particle size based on the ASHRAE Standard 2012.1,2.1,2-52.2

What is the MERV rating recommended for operating rooms?

ASHRAE Standard 2013-170, Ventilation of Health Care Facilities, provides standards and guidance on the design

requirements for ventilation systems utilized in health care facilities.3 The standard recommends that operating rooms

utilize a lter that is equivalent to MERV 14.3 This MERV rating is specic to the ventilation system in the hospital’s

operating room.

What is the MERV rating recommended for patient warming devices in the operating room?

There is no ltration standard for patient warming devices utilized within the operating room. The ASHRAE Standard is a

standard used to assess lter eciency in health care ventilation systems.

Is a HEPA filter necessary?

No. We are not aware of any evidence or claim demonstrating that a HEPA lter improves patient safety.

What is the ASHRAE 52.2-2012 standard?

The American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) is a global organization

focused on research, education and standards for heating, ventilation, air conditioning and refrigeration. The ASHRAE

standard 20121,2-52.2 provides test methods for air intake lters to ensure standardization in classication and

eciency. For more information on ASHRAE, please visit www.ashrae.org.

1. ANSI/ASHRAE Standard 2012-52.2: Method of Testing General Air Ventilation Air-Cleaning Devices for Removal Eciency by Particle

at http://www.ashrae.org. Accessed on 2016/7/6.

2. ANSI/ASHRAE Addenda a, b, and d to ANSI/ASHRAE Standard 2012-52.2. Method of Testing General Air Ventilation Air-Cleaning

Devices for Removal Eciency by Particle Size. The American Society of Heating, Refrigerating and Air-Conditioning Engineers, Inc.

3. ANSI/ASHRAE/ASHE Standard 2013-170: Ventilation of Health Care Facilities. The American Society of Heating, Refrigerating and Air-

Refer to the 3M™ Bair Hugger™ Model 775 warming unit Operator’s Manual for a complete list of instructions for use,

preventative maintenance, warnings and cautions. For more information about the Bair Hugger warming system, please

contact your 3M representative, call us at 3957-228-800-1 or visit www.bairhugger.com.

3M, BAIR HUGGER and the BAIR HUGGER logo are trademarks of 3M Company, used under license in Canada.

Made in the USA by

3M HealthCare

2510ConwayAve.

St. Paul, MN 55144U.S.A.

800-228-3957|www.bairhugger.com

3M, BAIR HUGGER and the

BAIRHUGGER logo are trademarks

of3M. Used under license in Canada.

Issue Date:2016-07

34-8718-8811-0

3M Deutschland GmbH

Health Care Business

Carl-Schurz-Str. 1

41453 Neuss

Germany

3M Bair Hugger™ Warming Units Operating instructions

3M Bair Hugger™ Warming Units Operating instructions

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